FDA.reportPublic FDA data

Edge Air

Primary DI
00869126000444
Brand
Edge Air
Company
OSKO, INC.
Model
Edge Air
Device description
Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems.
Published
2017-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172681000Edge Air Digital Flat Panel X-ray DetectorOsko, Inc.2017-10-06MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869126000444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869126000444008691260004448691260004440869126000444

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(305)599-7161info@oskomedical.com

Regulatory Flags#

DUNS number
017527767
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869126000451Smart StitchingSmart Stitching2017-11-16
00869126000468DCXDCX2019-06-10
00869126000437EdgeEdge2017-11-16
00869126000406RU3000RU30002017-11-16
00869126000413ELIANELIAN2017-11-16
00869126000420XR5 XR52017-11-16

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Primary DI, Brand, Company table
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